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IRB Operational Manager
1 month ago
The IRB Operational Manager is responsible for overseeing the daily operations of the Institutional Review Board (IRB), ensuring compliance with regulatory requirements and efficient processing of all types of research protocols. This role involves managing the full board, expedited, exempt, Non-Human Subject Research (NHSR), and reliance divisions within the IRB.
Key Responsibilities:
Oversee the daily coordination and facilitation of meetings of the full board, including scheduling, agenda preparation, and documentation.
Supervise the expedited review process, including the assignment of protocols to reviewers, monitoring timelines, and ensuring appropriate documentation of reviews.
Supervise the exempt review process, including the evaluation of research protocols for exemption criteria, documentation of determinations, and communication with researchers.
Supervise the review and approval process for research involving non-human subjects, such as tissue samples or data analysis, ensuring compliance with relevant regulations and institutional policies.
Supervise the facilitation of the establishment and management of reliance agreements with external institutions or entities, including negotiation, documentation, and ongoing communication to ensure compliance with regulatory requirements.
Requirements:
Bachelor's degree in a related field, such as healthcare administration, public health, or life sciences.
Minimum of 3 years of experience working as an IRB Operational Manager or equivalent.
Certified as a Certified IRB Professional (CIP).
Comprehensive understanding of relevant regulations and guidelines governing human subjects research, such as the Common Rule, FDA regulations, and HIPAA.
Strong organizational skills with the ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with researchers, IRB members, and external stakeholders.
Proficiency in Microsoft Office Suite and electronic research administration systems.
The candidate should have demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU.
About VCU:
Virginia Commonwealth University (VCU) is a premier, urban, public research university home to multiple nationally ranked programs. We combine learning, research, creativity, service, and discovery with a commitment to inclusive excellence. Our mission is to foster transformative research, discovery, and innovation at Virginia Commonwealth University through excellence in service.
